Clinical Trial to Analyze Lateralized Models and Medializations of Inverted Arthroplasty.

Not Applicable

Recruiting

• Conditions: Rotator Cuff Arthropathy; Glenohumeral Osteoarthritis
• Interventions: Procedure: reverse shoulder arthroplasty

• Registration Number: NCT05847062
• Lead Sponsor: Yaiza Lopiz Morales

Brief Summary

To determine the functional outcomes, complications and muscle performance by isokinetic study of two reverse arthroplasty systems (one with medialized center of rotation and the other with lateralized center of rotation) in the treatment of rotator cuff arthropathies or irreparable cuff tears.

Detailed Description

This is an experimental, prospective, unblinded, randomized, comparative clinical trial between patients with two types of prosthetic implants (inverted arthroplasty with medialized center of rotation vs inverted arthroplasty with lateralized center of rotation). Those male or female patients who meet the inclusion criteria will be selected to form part of one of the two randomly distributed study groups. Sample size Based on studies with similar characteristics but where lateralization is not performed with the implant but with a bone graft would require a sample size of 34 patients (17 in each group) assuming 20% losses with a Type I error of 0. 05 and a statistical power of 80% to show a difference of 10 points on the Constant scale (the minimal clinically important difference on the Constant scale for reverse arthroplasty is described as 8 points in previous comparative studies so we consider the detection of a difference of 10 to be sufficient. The minimal clinically important difference for function and strength in patients undergoing reverse shoulder arthroplasty. The final N needed would be 42 patients (21 per group). A randomization of patients will be performed to assign them to one or the other study group, which will be carried out by an independent assistant, who will generate a random sequence that will be unknown to the investigators. Each patient will be given a sealed and numbered envelope to choose from, in which the randomized group in which he/she has been included will be determined. The study will be blinded for the patient and rehabilitator but not for the surgeon.

Study Timeline

• Study Start: 2022-03-08
• Study First Submitted: 2023-02-28
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-03-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Male or female patients over 65 years of age with rotator cuff arthropathy refractory to conservative treatment after six months.
2. Ability to understand the information sheet, informed consent and evaluation scales.

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Exclusion Criteria

Patients with sequelae of fractures, rheumatoid arthritis, avascular necrosis, primary glenohumeral arthrosis, revision surgeries that have required conversion to a ATHI 3. Patients in whom another surgical procedure has been associated with ATHI such as a tendon transfer 4. Glenoid bone defects in the horizontal plane (Type B2 and C of the Walch classification) or in the vertical plane (E3 Sirveaux).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients operated on by means of an inverted shoulder prosthesis with medialized component	reverse shoulder arthroplasty	patients meeting the inclusion criteria who underwent surgery for a rotator cuff tear using an inverted shoulder prosthesis with a medially rotated center of rotation.
patients operated by means of inverted shoulder prosthesis with lateralized component	reverse shoulder arthroplasty	patients meeting the inclusion criteria who underwent surgery for a rotator cuff tear using an inverted shoulder prosthesis with a lateralized center of rotation.

Primary Outcome Measures

Name	Time	Method
to compare functional outcomes in patients with cuff arthropathies treated with medialized ATHI or lateralized ATHI.	24 Months	To compare functional outcomes (Constant scale score) 24 months after surgery in patients over 65 years of age with cuff arthropathies treated with either of two options: Medialized ATHI or lateralized ATHI. the score ranges from 0-100 points. The higher the score the better the functional result

Secondary Outcome Measures

Name	Time	Method
Comparison of the results of the visual analog pain scale (VAS)	24 Months	Comparison of the results obtained in the other functional assessment scale: the visual analog pain scale (VAS).(0-10). The higher the score, the more painful
Comparison of Joint Range of Motion between the two prosthetic systems under study.	24 Months	Comparison of the joint range of motion (joint balance in degrees in abduction, external and internal rotation, anteversion) between the two prosthetic systems under study.
Analysis and comparison of the Maximum recorded muscle force.	24 Months	Maximum muscle force at any time during a repetition. Indicative of muscle force capacity (N-M, newtons per meter).
Analysis and comparison of the Deceleration speed	24 Months	Deceleration speed: total time to go from Isokinetic speed to zero speed. Indicative of the neuromuscular capacity to control the limb eccentrically at the end of the Range of Motion (msec, milliseconds).
Analysis and comparison of the isokinetic parameters (Agonist/antagonist ratio)	24 Months	Agonist/antagonist ratio: The ratio of the reciprocal muscle group. Excessive imbalances may predispose to joint injury.%
Determination and comparison of the prevalence of complications with each of the prosthetic systems.	24 Months	Determination and comparison of the prevalence of complications with each of the prosthetic systems used, including radiographic evaluation.
Comparison of the results of the Quick Disabilities of arm, shoulder and hand (Quick-DASH) score.	24 Months	Comparison of the results obtained in the other functional assessment scale: Quick Disabilities of arm, shoulder and hand (Quick-DASH) score. The score ranges from 0 to 100.; The higher the score, the greater shoulder disability
Comparison of the results of the American Shoulder and Elbow Surgeons score	24 Months	Comparison of the results obtained in the other functional assessment scales: American Shoulder and Elbow Surgeons score. the the score ranges from 0 to 100, where 0 indicates a worse shoulder condition and 100 indicates best shoulder condition, so the greater the score, the lower the level of shoulder disability
Analysis and comparison of the Maximum strength as a function of weight	24 Months	Maximum strength as a function of weight: percentage of muscle strength recorded and normalized by body weight and compared to the set goal ( %).
Analysis and comparison of the Total work per repetition	24 Months	Total work per repetition: total muscle force for the repetition with the greatest amount of work. Work is indicative of the muscle's ability to produce force throughout the range of motion (measured in Joules (J)).
Analysis and comparison of the isokinetic parameter (Coefficient of variation )	24 Months	Coefficient of variation : Statistical representation of the validity of the test based on the reproducibility of the exercise. Low values show higher reproducibility (%).
Analysis and comparison of the isokinetic parameters (Average power)	24 Months	Average power: total work divided by time. Power represents how fast a muscle can produce force (W, watts).
Analysis and comparison of the Acceleration rate	24 Months	Acceleration rate: total time to reach the Isokinetic speed. Indicative of the neuromuscular capacity to move the limb at the beginning of the Range of Motion (msec. milliseconds).

Trial Locations

Locations (1)

Hospital Clinico San Carlos de Madrid; 🇪🇸 Madrid, Spain